Wall Street fled in droves after weight-loss devices maker EnteroMedics (NSDQ:ETRM) announced that its Maestro vagal blocking system failed to meet endpoints in a pivotal study, but the mass exodus isn’t discouraging the company from moving forward with a bid for FDA approval.
Treatment with Maestro therapy didn’t hit targets in the ReCharge study, but rates of excess weight loss combined with the demonstrated safety profile of the neurostimulation implant may be enough to get the device through the premarket approval process, the company reported.
"Even though we did not reach the predefined efficacy thresholds, data from the ReCharge trial clearly demonstrate VBloc Therapy’s positive effect on weight loss, while adding to an excellent safety record," EnteroMedics president & CEO Mark Knudson said in prepared remarks. "Based on these compelling results, and the totality of our clinical experience with the Maestro System, which now includes more than 600 patients worldwide, we believe EnteroMedics is well positioned to deliver this novel therapy to people with obesity in the U.S."
"We are moving forward with a PMA application to the FDA, in addition to advancing our plans for pursuing other indications, including obesity-related diabetes and hypertension, outside the U.S.," Knudson added.
ETRM shares opened at $2.97 on Feb. 7, 2013, prior to the release of the study results, and had sunk 56.6% by early afternoon today when they were trading at $1.29.
The study results, although shy of goals, demonstrated "a clinically meaningful and statistically significant excess weight loss (EWL) of 24.4% for VBloc Therapy-treated patients, with 52.5% of patients achieving at least 20% EWL," according to the press release.
EnteroMedics’ Maestro implantable therapy stimulates the Vagus nerve, located between the stomach and the esophagus, in order to alter a patient’s eating habits by modifying their physiological cravings.
"We tried to understand why people became over-weight and obese, and what was the underlying mechanism," Knudson told MassDevice.com in an interview last year. "As we looked into it more closely, we found that the autonomic nervous system – which is the body’s house-keeping nervous system, the nervous system that works outside of a person’s volitional control … was internally involved in the control of hunger, feelings of fullness, control of glucose, control of blood pressure."
"We’re the 1st company that’s developed really effective, commercially viable and available neural-blocking technology for the treatment of any problem," he added. "VBloc therapy uses very high frequency electrical signals to block the naturally occurring signals on the vagus nerve, on the autonomic nerve, from the brain to the stomach and the rest of the gut and from the gut and stomach to the brain."